FDA 510(k)

系統梅克斯自動血凝分析儀 CS-2100i

K 號：K151259 · 2016-01-26

申請人Siemens Healthcare Diagnostics Products GmbH

決定日期2016-01-26

產品代碼JPA

諮詢委員會HE 請提供完整的描述文本，以便我能夠進行翻譯。

決定相當於

器材摘要

Sysmex Automated Blood Coagulation Analyzer CS-2100i is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics Products GmbH. It received FDA 510(k) clearance on 2016-01-26 under 510(k) number K151259. The device is classified under product code JPA. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Sysmex Automated Blood Coagulation Analyzer CS-2100i?

Sysmex Automated Blood Coagulation Analyzer CS-2100i is a medical device that received FDA 510(k) clearance on 2016-01-26. The listed applicant is Siemens Healthcare Diagnostics Products GmbH. The 510(k) number is K151259.

When did Sysmex Automated Blood Coagulation Analyzer CS-2100i receive FDA 510(k) clearance?

Sysmex Automated Blood Coagulation Analyzer CS-2100i received FDA 510(k) clearance on 2016-01-26, under 510(k) number K151259.

Who is the listed applicant for Sysmex Automated Blood Coagulation Analyzer CS-2100i?

The FDA 510(k) record lists Siemens Healthcare Diagnostics Products GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sysmex Automated Blood Coagulation Analyzer CS-2100i?

The FDA product code for Sysmex Automated Blood Coagulation Analyzer CS-2100i is JPA.

其他以 Siemens Healthcare Diagnostics Products GmbH 為申請人之記錄

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相關器械（代碼：JPA）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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